The team has extensive experience, on the regulatory side as well as on the industry side, in dealing with registration dossiers up to electronic submission (for example Caddy for PPP, IUCLID for HPV/BPD and REACH). This includes identification of potential issues, product defense, strategy, technical task force management from List 1 products up to List 4 compounds (under 91/414/EEC).
Regulatory programmes/scheduling/budget for both existing and new active substances have been set up in close cooperation with clients to establish registration timelines under more and more severe Regulatory backgrounds. Our expertise includes also due diligence of chemicals.
While still involved in the implementation of 98/8/EC Directive for biocides, for both active substances and preparations, CEHTRA’s Regulatory team is now heavily involved in the preparation of numerous REACH dossiers.
CEHTRA is one of the leading consultancy groups in the E.U. in the domains of physico-chemistry, toxicology, ecotoxicology and environment as well as human and environmental risk assessment. Our expertise in these areas will be extremely valuable for the evaluation VpVb or PBT potential of your substances. We have even been actively involved in RIP 3.2-2 on PBT substances.
CEHTRA’s experience with exposure models as used in other E.U. directives have allowed us to swiftly master the models proposed in RIP 3.2.1 and in the TGD as well as any other type of relevant models or data and this will help to optimize the results to be included in the Chemical Safety Assessments / Chemical Safety Reports.
When studies have to be conducted, CEHTRA’s experience in over hundreds of studies monitored in different laboratories in and out of Europe will guarantee you the best design, follow up and use of any study you will have to conduct.
Our consultants have received advanced training in IUCLID 5 CEHTRA Several people in CEHTRA have already the experience of participating in or leading Consortia in the frame of E.U. regulations and are now doing so again in the first tier of the REACH registrations (we are involved in some of the biggest tonnage substances in Europe). We will be able to represent you in consortia and, if required, effectively defend a scientific position in the areas of physico-chemistry, toxicology, ecotoxicology and environmental exposure and provide you with a top quality dossier that not only passes the Technical Completeness Check, but also stand up to scientific scrutiny. We can also assist you in the scientific and financial evaluation of your own studies to optimize your position for cost sharing in SIEFs or Consortia.
CEHTRA also has the experience in creating and updating Safety Data Sheets (SDS) with the current C&L system as well as with GHS and is a forerunner in the preparation of the new e-SDS formats, in conjunction with several major consortia.
CEHTRA is involved in several REACH projects, some of them with world leaders of the chemical industry, dealing with:
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Strategic review of substance portfolio
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Data gap analysis
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Data entry into IUCLID 5
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Writing of CSA/CSR
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Communication with downstream users (DU) for the preparation of the CSA/CSR
Leader : Philippe ADRIAN
Other people involved :
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Estelle BELTRAN
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Virginie BUROSSE
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Marie DARRIET
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Lionel DIAFOUKA
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Laetitia FIEVEZ-FOURNIER
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Laurence GASNOT
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Michel GUILHEM
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Sara Jane KIRKHAM
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Angela LASSAILLY
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Carlo PONCIPE
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Pierre-Gérard PONTAL
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Mathieu ROLLAND
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Paul THOMAS
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Caroline VILLE